Skip to content

Liberal or Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma

Liberal or Adhere to Recommendations for Prothrombin Complex Concentrate Management in Major Bleeding Following Trauma:A Multicenter Retrospective Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06627218
Enrollment
650
Registered
2024-10-04
Start date
2021-01-01
Completion date
2025-12-31
Last updated
2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Bleeding

Keywords

trauma, Major Bleeding

Brief summary

Severe post-traumatic bleeding remains a major challenge in trauma management . The effectiveness and safety of PCC in the treatment of major traumatic bleeding is controversial, and the indications for use are not clear. Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.

Detailed description

Post-traumatic severe bleeding and associated traumatic coagulopathy remains a challenge. The use of prothrombin complex concentrate (PCC) is being explored in the management of on-going coagulopathy following trauma, with the cited purpose of boosting thrombin generation. Clinical data on the efficacy of PCC as part of a coagulation factor concentrate-based haemostatic strategy showed initial promising results in retrospective studies and meta-analysis. Certainly, the utility of PCC was a residual question in the management of traumatic coagulopathy. Uncertainty remains on the indication of use.The 2019 guideline on management of major bleeding and coagulopathy following trauma suggest that PCC should be administered to the bleeding patient based on evidence of delayed coagulation initiation using VEM, provided that fibrinogen levels are normal. The recommendation Grade is 2C.Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.

Interventions

Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Age ≥18 years old or \< 80 years old 2. Trauma treated in resuscitation unit/emergency room patient 3. Hospital admission within 24h after injury 4. Assessment of blood consumption (ABC) score ≥2 points.

Exclusion criteria

1. PCC was used before admission 2. Anticoagulant drugs (such as low molecular weight heparin, rivaroxaban, warfarin, etc.) 3. Previous venous thrombosis (VTE, Patients with a history of coronary artery stents within 3 months of pulmonary embolism and myocardial infarction) 4. Patients with traumatic cardiac arrest in hospital 5. Women during breastfeeding, pregnancy or pregnancy 6. Patients with hemophilia A and other blood system diseases, severe liver disease, cirrhosis and other coagulation dysfunction

Design outcomes

Primary

MeasureTime frameDescription
in-hospital mortality14 daysin-hospital mortality

Countries

China

Contacts

Primary Contactyongan xu, doctor
xuyongan2000@163.com13757164833
Backup Contactyangbo kang, master
1179619719@qq.com19858878803

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026